Status:
COMPLETED
Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control.
Lead Sponsor:
Bayer
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Patients having uncontrolled or poorly controlled hypertension are at risk of experiencing cardiovascular events such as myocardial infarction or stroke. To reduce this risk an appropriate antihyperte...
Eligibility Criteria
Inclusion
- Hypertension (office systolic blood pressure \> 135 mmHg), untreated or poorly controlled but stable antihypertensive regimen for \>/= 4 weeks
- Presence of type 2 diabetes mellitus or target organ damage (echocardiographic or electrocardiographic left ventricular hypertrophy or microalbuminuria)
- Presence of a metabolic syndrome, i.e at least two of the following \[(from letter (a) to letter(d)\] in patients with organ damage or at least one of the following \[from letter (b) to letter (d)\] in patients with diabetes mellitus: (a) impaired glucose tolerance (fasting plasma glucose 110 -125 mg/dl) (b )raised serum triglycerides (\>/= 150 mg/dl) or comitant use of statins for this indication(c) low HDL cholesterol (males: \< 40 mg/dl, females: \< 50 mg/dl)(d) waist circumference \>102 cm in men and \>88 cm in women
- Age: 18-75 years
- Negative pregnancy test in females
- Written informed consent
Exclusion
- Concomitant treatment with AT1-antagonists e.g. losartan, eprosartan, telmisartan) or calcium-antagonists (e.g. amlodipine, felodipine, isradipine, nifedipine, nimodipine).
- Concomitant treatment with any other antihypertensive medication that cannot be safely withdrawn at entry (i.e taken on a stable regimen for \>/= 4 week) and that won't possibly be kept stable over the whole duration of the study.
- Concomitant treatment with known cytochrome P450-3A4 inhibitors (e.g cimetidine, anti-HIV protease inhibitors e.g. ritonavir, azole anti-mycotics eg. Ketoconazole, digoxin, quinidine, tacrolimus) or inducers such as anti-epileptic drugs (eg. phenytoin, carbamazepine and phenobarbitone) or rifampicin
- Concomitant treatment with potassium sparingdiuretics.
- Malignant, severe or labile essential hypertension, orthostatic hypotension
- Cardiovascular shock
- Evidence of secondary form of hypertension, including coarctation of the aorta, hyperaldosteronism, renal artery stenosis or pheochromocytoma
- Myocardial infarction or unstable angina within the previous 12 months
- Severe cardiac valve disease
- Severe rhythm or conduction disorder:
- Cerebrovascular ischaemic event (stroke, transient ischaemic attack) within the previous 12 months
- History of intra-cerebral haemorrhage or sub-arachnoid haemorrhage within the previous 12 months
- Type 1 diabetes mellitus
- Proteinuria (determined by uristix)
- BMI \> 34
- Uncorrected hypokalemia or hyperkalemia, potassium outside the range 3.0 to 5.5 mmol/l
- Sodium depletion and/or hypovolemia
- Gastrointestinal disease resulting in the potential for malabsorption)
- Liver disease or transaminase (AST, ALT) levels \> 3 x the upper limit of normal range.
- Renal failure, creatinine \>2.0 mg/dl
- General
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT00750113
Start Date
October 1 2007
End Date
August 1 2009
Last Update
December 5 2014
Active Locations (43)
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1
Pozzilli, Isernia, Italy, 86077
2
Monza, Monza-Brianza, Italy, 20052
3
Somma Lombardo, Varese, Italy, 21013
4
Ancona, Italy, 60126